Quality System Engineer

Mechelen , Flanders, Belgium

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: Biocartis
Region: Mechelen , Flanders

The Quality Systems Engineer II is responsible to support the corporate quality oversight over general QMS requirements, developing of quality strategy, policies, processes, standards, and systems for the company.

Accountabilities

Driving quality system compliance, developing and improving Quality Systems processes, procedures and tools;

Introduce and maintain the Biocartis Enterprise Quality Management System (EQMS) application in a validated state;

Managing and administering User Accounts, user roles and permissions within the EQMS

Acting as the System Administrator for the Biocartis Enterprise Quality Management System (EQMS) application;

Developing and delivering training for the EQMS application, the Training process, the Document Control process and the Record Control process;

Take up the role of Training Coordinator in the EQMS;

Establishing and maintaining the secured records archive for authentic documentation (take up the role of Archive Coordinator);

Developing and implementing optimizations of the Biocartis Enterprise Quality Management System (EQMS), in collaboration with the external application and support provider;

Coordinate and execute the roll-out of changes in the Biocartis EQMS application;

Maintaining, monitoring and improving the Training process, the Document Control process and Record Control process;

Responsible for maintaining, monitoring and improving the Quality Event and Change Control (CR) processes;

Organizing and providing training of personnel in relation to management of Quality Events and Change Requests;

Coordinate the follow-up of Quality Events and CRs in close collaboration with all departments involved, to assure a timely mitigation of deficiencies by responsible functions/persons and escalating concerns as required;

Coordinating the Change Control Process (take up the role of CR Coordinator);

Analyzing performance of Quality System processes (Training, Document Control, Record Control, Event handling, CR, (internal/external) Audit, Software Validation) and providing KPIs for Quality Review meetings;

Responsible for execution & reporting of NCR recurrence analysis;

Take up the role of Quality Review Meeting (QRM) Coordinator;

Establishing and maintaining Baseline Monitoring of QMS processes, as part of the Process Performance Monitoring (PPM) process;

Taking up the role of Internal Auditor;

Establishing of the yearly internal audit plan, follow-up of the execution and report completion;

Preparing for ISO audits, partner audits and FDA inspection readiness by effective interaction with other stakeholders;

Participate in audits performed by external parties;

Responsible for maintaining the ISO supplier certificates in the EQMS;

Participate in the standards/guidance management: purchase standards, upload standards on the appropriate location and update the Standards Library and inform the relevant stakeholders.

Profile requirements

• Bachelor level in science (biomedical/pharma/biochemical/biotechnology) is required or equivalent through experience. Or a Masters degree or PhD in bio-engineering, chemical engineering, biomedical science, industrial pharmacy would be an asset.
• At least 5 years of experience in the function of Quality Engineer, Quality Control Engineer or Production Engineer in an:

- IVD Medical Device manufacturing environment

or

-pharma environment

or equivalent by experience.

• Applied knowledge of Good Documentation Practices / Good Manufacturing Practices.
• Good applied knowledge of procedures/work instructions in a strongly regulated industry (medical devices, pharma);
• Hands-on experience with a QMS system;
• Experience in participating in deviation investigations, determining root cause, and
• Developing corrective action plans is an asset;
• Customer focused;
• Very accurate and have an eye for detail;
• Excellent organization and prioritization skills, and able to adapt to changing priorities;
• Decision making skills from a quality / compliance perspective;
• Positive mindset and drive;
• Technical writing skills;
• Presentation skills;
• Familiar with electronic document/quality event management systems;
• Good analytical and conceptual thinking skills with the ability to solve key problems;
• Knowledge of QMS regulations and the different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, );
• Familiar with Good Manufacturing and Documentation Practices (GMP, GDP).
• Advanced MS Office skills (in particular Word, Excel & PowerPoint);
• Excellent communicator, verbally and in writing;
• Able to w

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